FDA issues health warning vs lollipop brand over unauthorized use of condom foil packs as wrapper

Aileen Cerrudo   •   February 12, 2020   •   789

The Food and Drug Administration (FDA) warns the public against the purchase and consumption of unregistered Dipzy Cornpop Lollipops.

The said Dipzy Cornpop Lollipops under the company MM Lucky Multisales Corporation has unauthorized use of Durex condom foil packaging as lollipop wrapper.

“The FDA was notified by the company Baranda & Associates that Durex condom foil packaging is being used as lollipop wrapper by the company MM Marketing reflected on its label,” according to the FDA advisory.

“The FDA verified that the above mentioned food products are not authorized and the Certificates of Product Registration have not been issued,” the advisory further reads.

Concerned establishments are also warned not to distribute the said food products.—AAC

FDA prepares for clinical trials on six COVID-19 vaccine candidates

Marje Pelayo   •   July 30, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) is set to launch the clinical trials on six drugs that are candidates for the treatment of coronavirus disease (COVID-19).

According to FDA Director General Eric Domingo, the selected drugs are based on the updates from the Department of Science and Technology (DOST), the agency that has been helping the FDA in searching for a potential vaccine for COVID-19.

The FDA, however, has not disclosed the details on the six candidate vaccines.

In addition to these, Domingo said the Philippines is now preparing to join the Phase 3 Clinical Trials together with other participating countries.

“Posibleng mag-apply at magsasagawa ng Phase 3 Clinical Trials on candidate COVID-19 vaccines sa bansa [We may apply and conduct a Phase 3 Clinical trials on candidate COVID-19 vaccines here in the country],” Domingo said. 

“Pinag-uusapan na rin ang pakikilahok ng Pilipinas sa gagawing Solidarity Vaccine Trials ng World Health Organization [There are also discussions on the participation of the Philippines in the upcoming Solidarity Vaccine Trials by the World Health Organization],” he added. 

Five of the 166 COVID-19 candidate vaccines that are already in the Phase 3 Clinical Trials include:

  • Sinovac
  • Sinopharm- Wuhan Institute of Biological Products
  • Sinopharm- Beijing Institute of Biological Products 
  • Astrazeneca- University of Oxford 
  • Moderna/ NIAD

The FDA clarified that though the agency is not involved in the clinical trials, it is the one that regulates the clinical products such as vaccines for public use.

Kapag napatunayan na ligtas at epektibo ang mga produktong ito, puwede na silang mag-apply for registration sa FDA upang maging available ang mga ito sa merkado,” Domingo explained.

[Once a product is proven safe and effective, the owner may apply for registration to the FDA so it may be available to the market.]

In his state of the nation address, President Rodrigo Duterte mentioned that a vaccine for COVID-19 may soon be out specifically by September this year. 

The FDA clarified, however, that developing a vaccine may take months to years, not to mention the strong scientific evidence from clinical trials and the effectiveness and safety of the product for human consumption. 

Nonetheless, the FDA is prioritizing the review of a number of applicants for potential vaccine and treatment for COVID-19.

The agency stressed, however, that there is no vaccine or drugs that have been approved yet to be taken by COVID-19 patients.

All drugs that have been selected for trial are still on trial stage and undergoing experts’ evaluation.

“Wala pa pong bakuna kontra COVID-19, kahit saang bansa [There is no vaccine yet for COVID-19 anywhere in the world],” he added.

The official advised the public to report to the agency any anti-COVID product that is being sold online through its email covidresponse@fda.gov.ph or at ereport@fda.gov.ph.

“Ipakita ninyo po sa amin. Ipadala ninyo po sa amin ang mga detalye at bahala po ang mga ahente namin na manghuhuli dahil mga manloloko po iyan [Show us the product. Send the details to us and our agents will track them and process their arrest because those are fraudulent],” Domingo stressed. –MNP (with reports from Aiko Miguel)

FDA warns against use of masks with valves vs COVID-19

Maris Federez   •   July 18, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) has urged the public not to use masks with valves as protection against the coronavirus disease (COVID-19).

In an interview, FDA Director-General Eric Domingo said masks with valves are not registered for medical purposes and they are manufactured only to provide protection against dust, such as those used in industrial firms.

Domingo pointed out that those who wear masks with valves are only provided one-way protection.

“Ang proteksyon niya one-way, eh ang gusto natin ang proteksyon ng mask ay two-way. Kung tayo ay walang sakit hindi tayo mahahawa, kung tayo ay may sakit hindi tayo manghahawa,” Domingo added.

Domingo advised that wearing medical and surgical masks is still best to be used in public, adding that even cloth masks will serve the purpose.

“Sa mga ospital o sa mga naga-alaga ng may sakit, gusto po talaga natin medical or surgical use na mga masks. Pero kung everyday use, kahit naman po mga cloth masks. Mas safe pa po ang mga regular masks na walang valve,” he said.

Domingo added that the FDA has also advised hospitals to prohibit the entry of persons wearing masks with valves.

On Friday (July 17), the Medical City Clinic, has released its advisory against wearing masks with valves, prohibiting those wearing such entry to its premises.

While masks with valves are designed to ease exhalation and decrease humidity for the wearer, they do not block…

Posted by The Medical City Clinic on Wednesday, 15 July 2020

Meanwhile, data from the Department of Health (DOH) shows that, as of 4PM of July 17, the total number of COVID-19 cases is now at 63,001.

The data also shows a total of 1,841 confirmed cases based on the total tests done by 76 out of 84 current operational labs.

The DOH likewise announced 311 recoveries that brings the total number of recoveries to 21,748. — /mbmf

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23 out of 163 potential COVID-19 vaccines under clinical trial—FDA

Aileen Cerrudo   •   July 16, 2020

The Food and Drug Administration (FDA) said 23 out of 163 potential vaccines for coronavirus disease (COVID-19) are currently under clinical testing stage.

According to FDA Director General Eric Domingo, two potential COVID-19 vaccines will be given to a larger group of people to see if it is effective and to further evaluate its safety.

The said vaccines are Astrazeneca, currently being developed in London, and Sinovac that is being developed in China.

Department of Health (DOH) Spokesperson Usec. Maria Rosario Vergeire said that the anti-flu drug Favipiravir or Avigan, from Japan is also nearing clinical trials.

“We are fortunate that the Japanese have reached out to us to help increase the sample size of their Avigan drug trial, a potential treatment to prevent people from dying from COVID-19,” she said.

Meanwhile, the FDA has confirmed that another potential vaccine is being developed in Russia. Domingo said it is currently in the advanced phase.

“Ginagamit na rin siya sa clinical trial ng ibang bansa mayroon din sa Japan, China, United States, Italy at Russia, (It is currently under clinical trial in other countries like Japan, China, United States, and Russia),” he said.

The medicine for Ebola Virus, Remdesivir, is currently under solidarity trial. Remdesivir is being used in other countries to treat severe COVID-19 patients. AAC (with reports from Aiko Miguel)

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